Diabetes Mellitus, Type 2
Conditions
Keywords
Vildagliptin, Type 2 diabetes, Insulin secretion, Beta cell
Brief summary
Type 2 diabetes results when the body does not produce enough insulin to regulate blood sugar. This study is designed to measure the effect of vildagliptin on the maximum insulin secretion by the pancreas.
Interventions
DRUGVildagliptin
Sponsors
Novartis
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
30 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Diagnosed with type 2 diabetes for at least 6 months * Patients whose diabetes is controlled by diet and exercise only or patients taking metformin * BMI in the range 22-45 * Blood glucose criteria must be met
Exclusion criteria
* Pregnancy or lactation * Type 1 diabetes or diabetes resulting from pancreatic injury * Cardiovascular complications as defined by the protocol * Significant diabetic complications as defined by the protocol Other protocol-defined inclusion/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in maximal insulin secretory capacity at 12 weeks | — |
| Durability of this effect after a 2-week washout | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in beta-cell sensitivity to glucose at 12 weeks | — |
| Durability of this effect after a 2-week washout | — |
| Chance from baseline in glucagon secretion at 12 weeks | — |
Outcome results
None listed